Breast Cancer, Breast Cancer Metastatic
Conditions
Keywords
breast cancer, MBC, metastatic breast cancer
Brief summary
The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \[adjuvant\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.
Interventions
BIOLOGICALES2B-C001
Vaccine; Administration with or without \[adjuvant\] every third week for a total of five vaccinations.
OTHERISA 51 VD
Adjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations.
Sponsors
ExpreS2ion Biotechnologies
Gouya Insights
VelaLabs
KKS MedUni Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, dose-escalating
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years at screening visit. * Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic BC, with HER2 IHC level 1+, 2+ (either FISH negative or positive), or IHC level 3+, after undergoing 2-3 lines of anticancer therapy. * Life expectancy of at least 3 months. * ECOG performance status 0-2. * Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator. * 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration \>140 ms, or evidence of prior infarction. * Recovered from side effects, adverse reactions, or adverse events due to prior therapy and/or surgery; any residual toxicities and toxicities related to current anticancer treatment must be ≤ Grade 2, except for alopecia, neuropathy or lymphoedema. * If female, non-pregnant, postmenopausal, or practicing reliable contraception. * If male, sterilized or using reliable contraception.
Exclusion criteria
* Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are neutropenic. Maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) for metastatic BC is allowed at the discretion of the treating physician. * Symptomatic CNS metastatic disease requiring treatment with high dose steroids (i.e., above 10 mg of prednisone or equivalent) within 14 days prior to first administration of ES2B-C001 (with or without adjuvant). * Concurrent or recent (within 21 days or 5 half-lives) involvement in any other clinical trial with an investigational drug, device, or other experimental intervention. * Concomitant severe or uncontrolled underlying medical and/or mental disease unrelated to the tumor, which in the opinion of the investigator is likely to compromise patient safety and affect the trial's outcome. * Previous documented coronary artery disease or congestive heart failure (\>NYHA II). * Echocardiography with LVEF \<50%. * Uncontrolled hypertension. * Active, known, or suspected autoimmune disease, except thyroid conditions sufficiently controlled on thyroid hormone therapy, and controlled insulin dependent diabetes. * Necessity for long-term immunosuppression (≤ 4 mg dexamethasone may be used transiently). * Systemic infection requiring intravenous antibiotics within 14 days before dosing. * Chronic use of anti-viral agents, except for human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV) treatments. * History of severe hypersensitivity reactions to any of the trial drug components. * Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated or recombinant vaccines/killed vaccines are allowed. * Birthmarks, tattoos, wounds, or skin conditions on deltoid region/buttocks that may obscure the assessment of injection site reactions. * Female patients who are pregnant, or lactating. * Any infection (including SARS-CoV-2), that in the opinion of the investigator would, upon inclusion in the trial, lead to potentially harming patients' safety or integrity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant]. | From enrolment to the end of study at week 18 | * Nature and frequency of dose-limiting toxicities (DLTs). * Incidence, nature and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. * Incidence, nature and severity of injection site reactions according to FDA Guidance on Toxicity Grading Scales in Vaccine Trials (FDA, 2007). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant]. | From enrolment to the end of study at week 18 | Immunogenicity as humoral immune response: Total anti-HER2 Immunoglobulin G (IgG) and IgG lambda titers in sera by enzyme-linked immunosorbent assay (ELISA). |
Countries
Austria
Contacts
STUDY_DIRECTORThomas K. Jorgensen
ExpreS2ion Biotechnologies
Outcome results
None listed